HFpEF - Heart Failure With Preserved Ejection Fraction study: Weight loss
Official title Tailored Exercise Training Study Among Adults With HFpEF
ClinicalTrials.gov ID: NCT07223242
What this study is testing
What is Weight loss medication (e.g., semaglutide or tirzepatide)?
An investigational use of weight loss drugs being studied as a potential treatment for heart failure with preserved ejection fraction (HFpEF). These drugs are designed to activate GLP‑1 receptors, which can reduce appetite and improve metabolic control.
Also referred to as semaglutide, tirzepatide.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether a home‑based exercise program can improve exercise ability and muscle health in people with HFpEF, and to compare four different lifestyle approaches.
- Who it's for
- Adults who have HFpEF or are at risk for this type of heart failure.
- What's involved
- Participants will follow a remote exercise training plan and may take part in other lifestyle programs, with periodic visits for fitness tests and muscle assessments.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age\>= 18 yrs
- LVEF (Left Ventricular Ejection Fraction) \>= 50%
- History of HFpEF or at risk of HFpEF
- HFpEF diagnosis based on:- -HF hospitalization within 12 months-
- NT-proBNP \>360 pg/mL
You likely can't join if
- Hospitalization 1 month prior to baseline visit
- History of recurrent falls
- eGFR (Estimated Glomerular Filtration Rate) \<20ml/min/1.73m
- Active changes in HF therapies over 2 weeks prior to baseline visit
- Inability participate in exercise training therapy
- Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
See the full eligibility criteria
- Age\>= 18 yrs
- LVEF (Left Ventricular Ejection Fraction) \>= 50%
- History of HFpEF or at risk of HFpEF
- HFpEF diagnosis based on:- -HF hospitalization within 12 months-
- NT-proBNP \>360 pg/mL
- Risk of HFpEF based on:-
- \>2 risk factors (h/o diabetes, hypertension, obesity, physical inactivity by self-report)
- SPPB \< 10 or VO2\<60th percentile
- BMI \>=28 (for randomization in phase II)
- Able to use cell phone and mobile application
- Hospitalization 1 month prior to baseline visit
- History of recurrent falls
- eGFR (Estimated Glomerular Filtration Rate) \<20ml/min/1.73m
- Active changes in HF therapies over 2 weeks prior to baseline visit
- Inability participate in exercise training therapy
- Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
- Severe left side valvular heart disease
- End stage pulmonary disease, requiring continuous supplemental oxygen
- Major surgery within 3 months of screening or major elective surgery during the duration of the study.
- Unstable weight defined by \>5% change in body weight in last 30 days before first study visit.
- Pregnancy
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.